GaitELASTOREPRONCT02960932
Reproducibility Inter-session of the Measurement Elastography of the Passive Stiffness of Medial Beams of Gastrocnemius Muscle of the Hemiplegic Cerebral Child.
A study testing ultrasound scanner in people with Gait and Child Development, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Muscles, paretics and spastics, of cerebral palsy children have very early, for growth (three at five aged), every alteration of theirs properties. Gastrocnemius muscle, often reaches on the cerebral palsy, characterised by a modification of the structure (volume decrease) and the elasticity (increase of the passive… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Gait, Child Development, Hemiplegic
- What is being tested?
- ultrasound scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2017to 10 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents affiliated or entitled to a social security;
- Children diagnosed spastic cerebral paralyzed, with a clinical picture of hemiplegia infantile cerebral;
- Children walking GMFCS (Gross Motor Functional Classification System) between I and III;
- Children with spasticity level in the paralysing gastrocnemius muscle greater than or equal X1, VII, on the scale of Tardieu and 2 on the Ashworth scale.
- Children aged 5 to 12 years.
- Children can understand and follow the simple instructions in the examination process.
- Consent signed by the holder of parental authority.
Who cannot join
- Children with concomitant muscle disease (myopathy ...).
- Children who received another treatment to target relaxant (baclofen, ... muscle relaxant) which would have begun in the months preceding the assessment.
- Children who underwent neuro-orthopedic surgery at the where paretic members.
- Children who received an injection of botulinic toxin for less than 15 days.
- Children who have benefited from extensions casts for less than 7 days.
- Children who received a therapeutic target for orthopedic (botulinum toxin, plaster of extensions, installation of equipment of lower limb) between the two sessions evaluations.
- Children who received a physiotherapy session the day before evaluation elastography and ultrasound.
Trial locations and contacts
1 site in 1 country.
About this study
Muscles, paretics and spastics, of cerebral palsy children have very early, for growth (three at five aged), every alteration of theirs properties. Gastrocnemius muscle, often reaches on the cerebral palsy, characterised by a modification of the structure (volume decrease) and the elasticity (increase of the passive stiffness). Every alterations of the muscular property have impact clinic and functional important. The many treatments of orthopaedic targeting (lengthening of cast, injections of botulinic toxin), repeated to a multiple recovery during the growth influences the muscular characteristics. There is a real interest to measure the muscular property development during children's growth.
Read the detailed description
Elastography is a technical assessment of characteristic of the soft tissues. In this area, the method " Supersonic Shear Imaging® (SSI) " provide an important technological change measuring, swiftly and no invasive, a elasticity modulus reflecting the property visco-elastic of the muscle. A lot of ex vivo study led in isolated muscle and in vivo in healthy adults demonstrated the validity of the method SSI on the evaluation of the passive stiffness from a number of muscle group whose the gastrocnemius muscle. The main objective of this study must be checked the intersession reproducibility of the method SSI on the evaluation of the passive stiffness at the medial bundle of the gastrocnemius muscle therefore their passive lengthening in cerebral palsy children. The secondary objective is to test the correlation level of the relation elasticity modulus/ joint angle and couple force-angle obtained throughout the passive lengthening at the medial bundle of the gastrocnemius muscle in cerebral palsy children.
- Conditions
- Gait, Child Development, Hemiplegic
- Being tested
- ultrasound scanner
- Keywords
- Hemiplegic, Child, Elastography, paralysis
- Medical subject headings
- Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound scannerDevice
Ultrasound scanner used to the SSI technical reproducibility.
| Study group | Role | What they receive |
|---|---|---|
| hemiplegic cerebral child | Experimental | Ultrasound scanner used to the SSI technical reproducibility. Receives: Device: ultrasound scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of elasticity modulus
To measure at the medial bundle of the gastrocnemius muscle at the passive mobilization of the ankle in the joint sector following: 30 degree in plantar and maximal dorsal flexion; calculation of yield curve of elasticity modulus, joint angle in kilopascals (kPa).
Measured: 7 days
Secondary outcomes (5)
Measure of force couple
Stored measure at the passive mobilization of the ankle in position of maximal dorsal flexion; calculation of yield couple of joint force-angle in nanometer.
Measured: 7 days
Measure of fascicular length
To measure at the medial bundle of the gastrocnemius muscle at the passive mobilization of the ankle in the selected joint sector (30 degree in plantar and maximal dorsal flexion); calculation of the difference of fascicular length in millimeter between the extreme position of joint sector: 30 degree in plantar and maximal dorsal flexion.
Measured: 7 days
Measure of pennation angle of the muscular fascicle
To measure at the medial bundle of the gastrocnemius muscle at the passive mobilization in the selected joint sector in degree; calculation of the difference of pennation angle of the muscular fascicle between the extreme position of joint sector: 30 degree in plantar and maximal dorsal flexion.
Measured: 7 days
Measure of elasticity modulus
Measure of elasticity modulus at the medial bundle of the gastrocnemius muscle in rest position kilopascals (kPa).
Measured: 7 days
Measure of muscle stiffness
Difference of muscle stiffness evaluated between the paretic and no paretic member.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start21 Feb 2017
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GaitStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Gautheron, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960932
- Sponsor's protocol ID
- 1608112
- Other IDs
- 2016-A01558-43
- Acronym
- ELASTOREPRO
- Status last verified
- Mar 2017
- First submitted
- 8 Nov 2016
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boulard C, Gautheron V, Lapole T. Reliability outcomes and inter-limb differences in ankle joint stiffness in children with unilateral cerebral palsy depend on the method of analysis. J Electromyogr Kinesiol. 2019 Dec;49:102353. doi: 10.1016/j.jelekin.2019.102353. Epub 2019 Aug 23.
PubMed 31473451
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility Inter-session of the Measurement Elastography of the Passive Stiffness of Medial Beams of Gastrocnemius Muscle of the Hemiplegic Cerebral Child.
- ClinicalTrials.gov ID
- NCT02960932
- Acronym / sponsor ID
- ELASTOREPRO / 1608112
- Conditions
- Gait, Child Development, Hemiplegic
- Keywords
- Hemiplegic, Child, Elastography, paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 10 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Muscles, paretics and spastics, of cerebral palsy children have very early, for growth (three at five aged), every alteration of theirs properties. Gastrocnemius muscle, often reaches on the cerebral palsy, characterised by a modification of the structure (volume decrease) and the elasticity (increase of the passive stiffness). Every alterations of the muscular property have impact clinic and functional important. The many treatments of orthopaedic targeting (lengthening of cast, injections of botulinic toxin), repeated to a multiple recovery during the growth influences the muscular characteristics. There is a real interest to measure the muscular property development during children's growth.
Detailed description
Elastography is a technical assessment of characteristic of the soft tissues. In this area, the method " Supersonic Shear Imaging® (SSI) " provide an important technological change measuring, swiftly and no invasive, a elasticity modulus reflecting the property visco-elastic of the muscle. A lot of ex vivo study led in isolated muscle and in vivo in healthy adults demonstrated the validity of the method SSI on the evaluation of the passive stiffness from a number of muscle group whose the gastrocnemius muscle. The main objective of this study must be checked the intersession reproducibility of the method SSI on the evaluation of the passive stiffness at the medial bundle of the gastrocnemius muscle therefore their passive lengthening in cerebral palsy children. The secondary objective is to test the correlation level of the relation elasticity modulus/ joint angle and couple force-angle obtained throughout the passive lengthening at the medial bundle of the gastrocnemius muscle in cerebral palsy children.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hemiplegic cerebral child | Experimental | Device: ultrasound scannerUltrasound scanner used to the SSI technical reproducibility. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parents affiliated or entitled to a social security;
- Children diagnosed spastic cerebral paralyzed, with a clinical picture of hemiplegia infantile cerebral;
- Children walking GMFCS (Gross Motor Functional Classification System) between I and III;
- Children with spasticity level in the paralysing gastrocnemius muscle greater than or equal X1, VII, on the scale of Tardieu and 2 on the Ashworth scale.
- Children aged 5 to 12 years.
Key exclusion criteria (7 listed)
- Children with concomitant muscle disease (myopathy ...).
- Children who received another treatment to target relaxant (baclofen, ... muscle relaxant) which would have begun in the months preceding the assessment.
- Children who underwent neuro-orthopedic surgery at the where paretic members.
- Children who received an injection of botulinic toxin for less than 15 days.
- Children who have benefited from extensions casts for less than 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound scannerUltrasound scanner used to the SSI technical reproducibility. | Device | hemiplegic cerebral child |
Primary outcome
Measure of elasticity modulus
Time frame: 7 days
To measure at the medial bundle of the gastrocnemius muscle at the passive mobilization of the ankle in the joint sector following: 30 degree in plantar and maximal dorsal flexion; calculation of yield curve of elasticity modulus, joint angle in kilopascals (kPa).
5 secondary outcomes
Measure of force couple
Time frame: 7 days
Measure of fascicular length
Time frame: 7 days
Measure of pennation angle of the muscular fascicle
Time frame: 7 days
Measure of elasticity modulus
Time frame: 7 days
Measure of muscle stiffness
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Derived from this study: PubMed 31473451Boulard C, Gautheron V, Lapole T. Reliability outcomes and inter-limb differences in ankle joint stiffness in children with unilateral cerebral palsy depend on the method of analysis. J Electromyogr Kinesiol. 2019 Dec;49:102353. doi: 10.1016/j.jelekin.2019.102353. Epub 2019 Aug 23.
- Individual participant dataSharing planned: No
Related trials for Gait
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Gautheron, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound scanner in people with Gait and Child Development, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of elasticity modulus (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02960932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.